Spinal Cord Injury
Conditions
Keywords
tDCS, motor training, SCI
Brief summary
The study investigates the effect of using transcranial direct current stimulation (tDCS) and skilled stepping training versus skilled stepping training with sham-tDCS in improving ankle and leg motor control in persons with ambulatory persons with spinal cord injury. Hypotheses H1: Participants will display greater improvement in stepping function following tDCS combined with training compared to sham-tDCS and training. H2: Participants will display greater gains in cortical excitability, as evidenced by lower cortico-motor threshold (MT) associated with the TA muscles following tDCS and training compared to following sham stimulation and training. H3: Participants in the tDCS+training group will show greater increases walking speed in a timed 10 meter walking trial. H4: Participants in the tDCS+training group will show be able to perform a greater number of toe-taps test.
Detailed description
An estimated 265,000 individuals live with the consequences of SCI in the United States alone. Individuals with motor incomplete spinal cord injury (MISCI) commonly experience loss or impairment of lower extremity function. There are a limited number of options for restoration of walking function in individuals with motor-incomplete spinal cord injury (MISCI) who exhibit some ability to stand and walk but may be impeded by impaired voluntary control of the lower limb particularly, the ankle. In persons with spinal cord injury, walking function is often limited by poor ability to lift and advance the legs. Lower extremity orthotic devices may be employed to stabilize the ankle joint and provide toe clearance during walking. However, these devices are cumbersome, and may be aesthetically unappealing. Newer evidence indicates that non-invasive approaches to brain stimulation may provide a way to improve voluntary control of the legs and ankles in persons with neurologic disorders. Purpose of this research study: The overall goal of this study is to develop functional rehabilitation strategies that facilitate optimal restoration of leg and ankle motor control in individuals with MISCI. Individuals with MISCI exhibit some motor function below the level of lesion and include American Spinal Injury Association Impairment Scale (AIS) classifications AIS C and AIS D. We propose to test non-invasive cortical stimulation in combination with lower-extremity functional motor training for its ability to assist in improving fine motor control of the lower limbs in individuals with MISCI. Studies have shown that non-invasive transcranial direct current stimulation (tDCS) can increase activity in specific cortical areas associated with motor learning, and therefore improve on the cortical and functional effects associated with motor practice training in individuals with SCI. If brain stimulation in combination with motor training is found to enhance improvements in control more effectively than motor training alone, this would provide a basis for further examining stimulation combined with lower limb joint therapy in individuals with spinal cord injury. Objectives: To Assess improvements in lower extremity motor control that are associated with bilateral tDCS and functional motor training or sham tDCS and functional motor training in individuals with motor incomplete spinal cord injury.
Interventions
DEVICETranscranial direct current stimulation + step training
Direct current stimulation of motor cortex with low stimulation intensity
BEHAVIORALSham transcranial direct current stimulation + step training
Stepping over specified soft foam obstacles
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Motor incomplete Spinal cord injured subjects. * Ability to walk 10 m with or without walking aides. * Ability to Dorsiflex (Move foot up) at least 5 degrees from sitting.
Exclusion criteria
* Seizures * Cognitive function impairment * Brain surgery or intracranial metal implants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Midswing Ankle ROM | Two times, 1) Baseline, and 2) Up to 1 hour after intervention. | Measuring Ankle range of motion (ROM) first at Baseline and then up to 1 hour after intervention at the Midswing phase during Gait. |
| Change From Baseline Active Motor Threshold | Two times, 1) Baseline, and 2) Up to 1 hour after intervention. | Measuring Active motor threshold using single pulse transcranial magnetic stimulation (TMS) of Motor cortex M1 area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Scores of a 10 m Walk Test | Two times, 1) Baseline, and 2) Up to 1 hour after intervention. | Change from baseline score of the time required to perform 10 m walking. |
| Change From Baseline Score on Toe Tap Test | Two times, 1) Baseline, and 2) Up to 1 hour after intervention. | Measuring the Time required to perform toe taps |
Countries
United States
Participant flow
Pre-assignment details
One participant withdrew before assignment
Participants by arm
| Arm | Count |
|---|---|
| Real tDCS - Sham tDCS Real tDCS+skilled training
Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity
Step training: Stepping over specified soft foam obstacles
Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles
Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Step training: Stepping over specified soft foam obstacles | 0 |
| Sham tDCS - Real tDCS Sham tDCS+skilled training
Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Step training: Stepping over specified soft foam obstacles
Real tDCS+skilled training
Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity
Step training: Stepping over specified soft foam obstacles | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | — Participants |
| Age, Categorical >=65 years | — Participants |
| Age, Categorical Between 18 and 65 years | — Participants |
| Sex: Female, Male Female | — Participants |
| Sex: Female, Male Male | — Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change From Baseline Active Motor Threshold
Measuring Active motor threshold using single pulse transcranial magnetic stimulation (TMS) of Motor cortex M1 area
Time frame: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Population: Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.
Primary
Change From Baseline Midswing Ankle ROM
Measuring Ankle range of motion (ROM) first at Baseline and then up to 1 hour after intervention at the Midswing phase during Gait.
Time frame: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Population: Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.
Secondary
Change From Baseline Score on Toe Tap Test
Measuring the Time required to perform toe taps
Time frame: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Population: Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.
Secondary
Change From Baseline Scores of a 10 m Walk Test
Change from baseline score of the time required to perform 10 m walking.
Time frame: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Population: Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.